Clinical trial · Observational
Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer
Consistency Between Treatment Responses in Patient-Derived Organoid (PDO) Models and Clinical Outcomes of Neoadjuvant Therapy, Conversion Therapy and Palliative Therapy in Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastric cancer is the fourth leading cause of cancer-related death worldwide. Accurate assessment of the clinical responses to current treatment regimens is key to improving the prognosis and prolonging the survival of patients. In this study, two hundred and fifty patients with gastric cancer who ought to receive neoadjuvant therapy, conversion therapy or palliative chemotherapy will be enrolled, and patient-derived organoids from their tumor biopsies will be used to test the sensitivity of chemotherapy drugs which mainly include 5-fluorouracil, irinotecan, oxaliplatin and paclitaxel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Gastric cancer patients
- description
- Patients with gastric cancer will undergo tumor biopsy before receiving neoadjuvant therapy, conversion therapy, or palliative therapy
- interventionNames
- Procedure: Tumor biopsy
Primary outcomes (1)
- measure
- Establishment of patient-derived organoids
- timeFrame
- 2021.05 - 2023.12
- description
- Patient-derived organoids (PDOs) will be established from gastric cancer tumor specimens and the rate of successful generation of gastric cancer organoids will be calculated.
Secondary outcomes (1)
- measure
- Correlation between results of the drug sensitivity tests in patient-derived organoid models and clinical outcomes
- timeFrame
- 2021.05 - 2023.12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 18 to 70 years old, no gender limit 2. The primary tumor is diagnosed as gastric adenocarcinoma (papillary, tubular, signet ring cell, poorly differentiated and mucinous adenocarcinoma) by endoscopic biopsy sampling and follow-up histopathological staining 3. The pre-operative staging includes: a) Stage IVa（cT4bNanyM0），resectable; b) Stage II-III（cT1-2N1-3M0、cT3-4aN0-3M0）, gastro-oesophageal junction (GEJ) cancer；c) Stage III（cT3-4aN1-3M0）, non-GEJ cancer, appropriate for neoadjuvant therapy 4. Stage IVb or locally unresectable late-stage gastric or GEJ cancer, previously never received chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 6. The function of major organs is normal, meeting the following criteria: a) routine blood tests (no blood transfusion in the past 14 days): HB≥90g/L；ANC ≥1.5×109/L；PLT ≥80×109/L；b）blood biochemical parameters: BIL \<1.5-fold upper limit of normal (ULN)；ALT\<2.5×ULN; AST\<2.5×ULN；Crea≤1×ULN 7. Fresh tumor tissue biopsies are obtainable and the clinical information of the patients is complete 8. Patients have been informed and consented Exclusion Criteria: 1. Previously received neoadjuvant therapy 2. Previously had other types of malignancy and received chemotherapy or radiotherapy 3. Previously had chicken pox, herpes zoster or other severe contagious diseases 4. Have severe active ulcer (gastrointestinal tract, skin, etc.) or have developed a high fever 5. Have a medical history of myocardial infarction, cerebral infarction, or pulmonary embolism 6. Have complications of gastric cancer (bleeding, perforation and obstruction etc.) and need emergency operation 7. Pregnant or lactating women 8. Have severe mental diseases 9. Allergic to chemotherapy drugs 10. Have metastatic brain cancer 11. Refuse to cooperate and to complete a treatment
References
Publications (0)
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